A study to compare two treatments to patients with STEMI or NSTEMI. The study will evaluate all cause death, myocardial infarction, stroke, stent trombosis and bleeding after treated with PCI - Percutaneous coronary intervention

Bivalirudin versus Heparin in NST and ST-Evaluation myocardial infarction on modern antiplatelet therapy in SWEDEHEART (the VALIDATE - SWEDEHEART-trial) - VALIDATE-SWEDEHEART-trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005260-10-SE

Enrollment

6000

Registered

2012-12-17

Start date

2013-02-11

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with STEMI and NSTEMI treated with PCI and either Bivalirudin (optional to add up to 3000U heparin in lab or up to 5000U given prehospital ) compared to Heparin 70 - 100U/kg alone MedDRA version: 17.1 Level: LLT Classification code 10064347 Term: Non ST segment elevation myocardial infarction System Organ Class: 100000004849 MedDRA version: 17.1 Level: LLT Classification code 10064345 Term: ST segment elevation myocardial infarction System Organ Class: 100000004849

Interventions

Trade Name: Angiox Pharmaceutical Form: Powder for concentrate for solution for injection/infusion INN or Proposed INN: BIVALIRUDIN CAS Number: 128270-60-0 Concentration unit: mg/ml milligram(s)/milli

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients with a diagnosis of NSTEMI as judged by the physician in accordance with current guideline definitions (positive troponin) or patients with a diagnosis of STEMI as defined by chest pain suggestive for myocardial ischemia for at least 30 minutes before hospital admission, time from onset of symptoms of less than 24 hours, and an ECG with new ST-segment elevation in two or more contiguous leads of =0.2 mV in leads V2-V3 and/or =0.1 mV in other leads or a probable new-onset left bundle branch block. - PCI of culprit lesion is intended (therapeutic PCI, not primarily diagnostic PCI). - Ability to provide informed consent - Age 18 years or older - Treated with bolus dose of ticagrelor or prasugrel before start of PCI Age 18 years or older Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 3000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3000

Exclusion criteria

Exclusion criteria: - Previous randomization in the VALIDATE-SWEDEHEART trial - Known terminal disease with life expectancy less than one year. - Patients with known ongoing bleeding - Patients with uncontrolled hypertension in the opinion of the investigator - Patients with known subacute bacterial endocarditis - Patients with known severe renal (GFR 5000U before arriving to PCI lab or >3000U given during angiography before randomization - GpIIb/IIIa-inhibitors have been given or are pre-planned to be given during the procedure.

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare all cause death, MI, stroke, stent thrombosis and bleeding event in patients with STEMI and NSTEMI treated with PCI and either Bivalirudin 1.75 mg/kg followed by an infusion of 1.75 mg/kg per hour (optional to add up to 3 000 U heparin in lab or up to 5000 U given prehospital) or heparin 70 - 100 U/kg alone Endpoints at 180 days (primary time point). - After analysis of interaction, separate analysis of the primary endpoint in the NSTEMI and STEMI groups. ;Secondary Objective: - Time to individual components of the primary end point see above - The primary end point combined with stroke - Primary end point in heparin subgroups based on total heparin, U/kg, max ACT. - TIMI flow grade after PCI. - Time to re-hospitalization with reinfarction as reported in SWEDEHEART. - Time to all-cause death or re-hospitalization with myocardial infarction (first occurring). - Time to target vessel revascularization as reported in SWEDEHEART. - Time to target lesion revascularization as reported in SWEDEHEART. - Time to stent thrombosis, time to restenosis, time to re-hospitalization with heart failure as reported in SWEDEHEART. - Heart failure and complications of PCI during index hospitalization, minor bleeding during index hospitalization as reported in SWEDEHEART - Length of index hospital stay as reported in SWEDEHEART. - Bail-out use of GpIIb/IIIa inhibitors during PCI.;Primary end point(s): Death, myocardial infarction and major bleeding event in patients at 180 days;Timepoint(s) of evaluation of this end point: Evaluation of primary endpoints 180 days after the event.	—

Measure

Time frame

Main Objective: Compare all cause death, MI, stroke, stent thrombosis and bleeding event in patients with STEMI and NSTEMI treated with PCI and either Bivalirudin 1.75 mg/kg followed by an infusion of 1.75 mg/kg per hour (optional to add up to 3 000 U heparin in lab or up to 5000 U given prehospital) or heparin 70 - 100 U/kg alone Endpoints at 180 days (primary time point). - After analysis of interaction, separate analysis of the primary endpoint in the NSTEMI and STEMI groups. ;Secondary Objective: - Time to individual components of the primary end point see above - The primary end point combined with stroke - Primary end point in heparin subgroups based on total heparin, U/kg, max ACT. - TIMI flow grade after PCI. - Time to re-hospitalization with reinfarction as reported in SWEDEHEART. - Time to all-cause death or re-hospitalization with myocardial infarction (first occurring). - Time to target vessel revascularization as reported in SWEDEHEART. - Time to target lesion revascularization as reported in SWEDEHEART. - Time to stent thrombosis, time to restenosis, time to re-hospitalization with heart failure as reported in SWEDEHEART. - Heart failure and complications of PCI during index hospitalization, minor bleeding during index hospitalization as reported in SWEDEHEART - Length of index hospital stay as reported in SWEDEHEART. - Bail-out use of GpIIb/IIIa inhibitors during PCI.;Primary end point(s): Death, myocardial infarction and major bleeding event in patients at 180 days;Timepoint(s) of evaluation of this end point: Evaluation of primary endpoints 180 days after the event.

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Secondary

Measure	Time frame
Secondary end point(s): Main Secondary endpoints: Endpoints at 180 days (primary time point). - After analysis of interaction, separate analysis of the primary endpoint in the NSTEMI and STEMI groups. - Time to individual components of the primary end point (death, myocardial infarction and major bleeding). - The primary end point combined with stroke as reported in the Swedish national patient registry. (These data will be available with a delay of about a year). - Primary end point in heparin subgroups based on total heparin, U/kg, max ACT. - TIMI flow grade after PCI. - Time to re-hospitalization with reinfarction as reported in SWEDEHEART. - Time to all-cause death or re-hospitalization with myocardial infarction (first occurring). - Time to target vessel revascularization as reported in SWEDEHEART. - Time to target lesion revascularization as reported in SWEDEHEART. - Time to stent thrombosis as reported in SWEDEHEART. - Time to restenosis as reported in SWEDEHEART. - Time to re-hospitalization with heart failure as reported in SWEDEHEART. - Heart failure and complications of PCI during index hospitalization as reported in SWEDEHEART. - Minor bleeding during index hospitalization as reported in SWEDEHEART - Length of index hospital stay as reported in SWEDEHEART. - Bail-out use of GpIIb/IIIa inhibitors during PCI. End points at 1 year, 2 years, 3 years, 5 years and 10 years. Annual analyses will be considered confirmatory only if all previous analyses have been significant. Health Economy - Economic evaluation based on cost-effectiveness analysis after 180 days with long-term modeling. - Health related quality of life (HRQOL) measured by Euro-Qol 5D (EQ-5D) using the SEPHIA registry. - Optional cost-effectiveness analyses at 1 year, 2 years, 3 years, 5 years and 10 years if clinical findings are revised. ;Timepoint(s) of evaluation of this end point: After 180 days, 1 year, 2 year, 3 year, 5 years and 10 years	—

Measure

Time frame

Secondary end point(s): Main Secondary endpoints: Endpoints at 180 days (primary time point). - After analysis of interaction, separate analysis of the primary endpoint in the NSTEMI and STEMI groups. - Time to individual components of the primary end point (death, myocardial infarction and major bleeding). - The primary end point combined with stroke as reported in the Swedish national patient registry. (These data will be available with a delay of about a year). - Primary end point in heparin subgroups based on total heparin, U/kg, max ACT. - TIMI flow grade after PCI. - Time to re-hospitalization with reinfarction as reported in SWEDEHEART. - Time to all-cause death or re-hospitalization with myocardial infarction (first occurring). - Time to target vessel revascularization as reported in SWEDEHEART. - Time to target lesion revascularization as reported in SWEDEHEART. - Time to stent thrombosis as reported in SWEDEHEART. - Time to restenosis as reported in SWEDEHEART. - Time to re-hospitalization with heart failure as reported in SWEDEHEART. - Heart failure and complications of PCI during index hospitalization as reported in SWEDEHEART. - Minor bleeding during index hospitalization as reported in SWEDEHEART - Length of index hospital stay as reported in SWEDEHEART. - Bail-out use of GpIIb/IIIa inhibitors during PCI. End points at 1 year, 2 years, 3 years, 5 years and 10 years. Annual analyses will be considered confirmatory only if all previous analyses have been significant. Health Economy - Economic evaluation based on cost-effectiveness analysis after 180 days with long-term modeling. - Health related quality of life (HRQOL) measured by Euro-Qol 5D (EQ-5D) using the SEPHIA registry. - Optional cost-effectiveness analyses at 1 year, 2 years, 3 years, 5 years and 10 years if clinical findings are revised. ;Timepoint(s) of evaluation of this end point: After 180 days, 1 year, 2 year, 3 year, 5 years and 10 years

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Countries

Iceland, Sweden

Contacts

Public ContactDepartment of Cardiology

Skåne University Hospital

david.erlinge@med.lu.se+46+4617 25 972597

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026